ICG Angiography in Amniotic Membrane Graft and Conjunctival Autograft After Pterygium Excision

Pterygium Clinical Trial

Official title:

Interventional Study of Vascularization Detected by ICG Angiography in Amniotic Membrane Graft and Conjunctival Autograft After Pterygium Excision

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00383825
• Other study ID #: B02-123456-2
• Status: Completed
• Phase: N/A
• First received: October 2, 2006
• Last updated: October 2, 2006
• Start date: January 2003
• Est. completion date: December 2004

Study information

• Verified date: October 2006
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

To evaluate graft vascularization and compare the vascularization patterns of conjunctival autografts with amniotic membrane grafts to better understand the factors involved in pterygium recurrence.

Description:

The vascularization and perfusion of conjunctival autografts and amniotic membrane grafts after surgery may have significance in terms of pterygium recurrence and progression. Fluorescein angiography of the anterior ocular segment has been used to evaluate ocular inflammation in scleral inflammation. However, when fluorescein is used, the quality of the angiograms is limited by rapid extravasation of the dye due to diffusion through the fenestrated capillaries of the conjunctiva and episclera. Because fluorescein has a low molecular weight and is not a protein bound molecule, patchy leakage during the first transit of the dye, which obscures the angiographic details even before the late phases of the angiogram, can be seen.

In contrast, indocyanine green (ICG) is a larger molecule than fluorescein and is more highly found in protein bound form. Therefore, it remains within the fenestrated vessels and shows negligible extravasation, which makes it ideal for use in anterior segment angiography.

Tan and coworkers have shown that the morphology of pterygium recurrence inevitably reflects a high degree of vascularity.

In this prospective study, we evaluated the anterior segment indocyanine green angiography (ICGA) findings for graft vascularization after primary pterygium excision with LCAT or AMT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients who had primary pterygium

Exclusion Criteria:

• Patients with major systemic diseases (eg, diabetes), vascular disease (excluding hypertension), serious ocular surface disease (eg, cicatricial pemphigoid), glaucoma and previous history of ocular surgery

• Patients with pterygia of both eyes

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Screening

Related Conditions & MeSH terms

• Pterygium

Intervention

Procedure:
• Anterior segment indocyanine green angiography

Locations

Country	Name	City	State
Turkey	Baskent University Hospital Department of Ophthalmology	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	After intravenous injection of ICG dye, photographs were taken at approximately 1- to 2-second intervals until the first appearance of the dye, and then at 10-second intervals for the next 4 minutes.
Primary	Thereafter, photographs were captured at 5, 10, and 20 minutes.
Primary	ICGA results of all patients were evaluated at monthly intervals after surgery.
Primary	Showing the re-vascularization during the follow-up period was the primary measure.